American Contract Systems recalled 32,433 cardiac cath lab kits distributed nationwide to healthcare providers. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process. The kits have not been validated for exposure to multiple sterilization cycles and cannot be guaranteed safe.
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
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Medical convenience kits are used in cath lab procedures and include packs for left heart caths and angiography. They are designed for single-use in sterile environments.
Re-gassing after EO sterilization may compromise sterility and device performance if cycles exceed validated limits.
This recall is not described as part of a broader industry pattern.
Hospitals may experience procedure delays or require alternate supplier arrangements while affected kits are identified and replacement materials are provided.
UDI-DI is printed on packaging; lot numbers and bag serial numbers are on the bag labels.
4-8 weeks for replacement or remediation after recall initiation.
Keep recall letter, product labels, UDI-DI, lot numbers, and bag serial numbers. Photograph packaging and maintain an inventory list.
Model numbers include EVLH67F, FDCL22R, IHCC03X, TNCC02AD, UICC27AG, UIRD89AH, and AMCL05P. Items described as LEFT HEART CATH PACK, CATH LAB ANGIO, CATH CARDIAC PACK, CARDIAC CATH TRINITY, CARDIAC CATH ANGIO PACK, and RADIAL PACK. US nationwide distribution to healthcare providers, with state distribution listed as SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Quantity: 32,433 units. Manufacturer: American Contract Systems. No consumer retailers identified. Price information not provided.
No injuries or incidents have been reported.
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